Chronic Pelvic PainNCT00554320
Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain
A study testing tDCS in people with Chronic Pelvic Pain and Interstitial Cystitis, run by Summa Health System at 1 site in United States.
Trial summary
We will rigorously test whether modulation of the motor cortex by transcranial direct current stimulation (tDCS) is an effective treatment for patients with chronic pelvic pain through the following specific aims: A) The primary aim of this study is to determine whether transcranial direct current stimulation applied… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Chronic Pelvic Pain, Interstitial Cystitis, Post Traumatic Stress Disorder
- What is being tested?
- tDCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must be females between 18 and 55 years of age.
- Subjects must have a current VAS for pelvic pain of 5 or more.
Who cannot join
- Known pelvic malignancy.
- Patients with major depression with suicidal risk as clinically defined.
- Patients with other known, uncontrolled neuropsychiatric disorders.
- Abnormal neurological examination other than as signs of the condition studied in the present protocol.
- Contraindication to tDCS:
- A history of unmanaged substance abuse or dependence within the last 6 months.
- A history of previous treatment with tDCS.
Trial locations and contacts
1 site in 1 country.
About this study
We will rigorously test whether modulation of the motor cortex by transcranial direct current stimulation (tDCS) is an effective treatment for patients with chronic pelvic pain through the following specific aims:
- The primary aim of this study is to determine whether transcranial direct current stimulation applied to the motor cortex in patients with chronic pelvic pain induces a significant decrease in the pain or symptoms as compared with sham tDCS. We will also measure changes in the clinical symptom scores of multiple pelvic organs, drug intake (narcotic), anxiety, depression, traumatic stress, as well as overall improvement in the quality of life to assess the effects of this treatment.
- Determine the duration of the clinical effects of tDCS. We will therefore compare the amelioration of pain and related symptoms between active and sham tDCS for one year following treatment.
- Determine whether tDCS changes the threshold for pain detection as compared with sham tDCS. Patients with chronic pelvic pain have a lower threshold for pain as compared to healthy subjects and we hypothesized that this threshold will increase after stimulation with tDCS.
- Finally, we will examine whether 5 days of tDCS treatment is safe for use in chronic pelvic pain patients. Safety will be assessed through neuropsychological tests and adverse event reporting.
- Conditions
- Chronic Pelvic Pain, Interstitial Cystitis, Post Traumatic Stress Disorder, Fibromyalgia, Irritable Bowel Syndrome
- Being tested
- tDCS
- Keywords
- vulvodynia, painful bladder syndrome, myofascial pain syndrome, pelvic floor tension myalgia
- Medical subject headings
- Cystitis, Interstitial, Stress Disorders, Post-Traumatic, Fibromyalgia, Irritable Bowel Syndrome, Vulvodynia, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSProcedure or surgery
During each session, the anode electrode will be placed on the motor cortex (contralateral to the most [or predominant] painful side [or the side where the symptoms begin or the left as a default]) and the cathode will be placed over the contralateral supraorbital area. In active tDCS subjects, 1 mA of transcranial direct current stimulation will be applied for 30 minutes.
tDCSProcedure or surgery
For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | During each session, the anode electrode will be placed on the motor cortex (contralateral to the most [or predominant] painful side [or the side where the symptoms begin or the left as a default]) and the cathode will be placed over the contralateral supraorbital area. In active tDCS subjects, 1 mA of transcranial direct current stimulation will be applied for 30 minutes. Receives: Procedure: tDCS |
| C | Placebo comparator | For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds. Receives: Procedure: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Assessment (PGA):
Measured: 2 weeks
Visual analog scale (VAS) for pain:
Measured: 2 weeks
Secondary outcomes (1)
Interstitial cystitis symptom index:
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Summa Health System
- Sponsor type
- University, hospital or other
- Investigators
- Bradford W Fenton, MD, PhD, Principal investigator, Summa Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554320
- Sponsor's protocol ID
- RP07066
- Status last verified
- Sep 2009
- First submitted
- 2 Nov 2007
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT00554320
- Acronym / sponsor ID
- RP07066
- Conditions
- Chronic Pelvic Pain, Interstitial Cystitis, Post Traumatic Stress Disorder, Fibromyalgia, Irritable Bowel Syndrome
- Keywords
- vulvodynia, painful bladder syndrome, myofascial pain syndrome, pelvic floor tension myalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Summa Health SystemUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 6 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will rigorously test whether modulation of the motor cortex by transcranial direct current stimulation (tDCS) is an effective treatment for patients with chronic pelvic pain through the following specific aims:
- The primary aim of this study is to determine whether transcranial direct current stimulation applied to the motor cortex in patients with chronic pelvic pain induces a significant decrease in the pain or symptoms as compared with sham tDCS. We will also measure changes in the clinical symptom scores of multiple pelvic organs, drug intake (narcotic), anxiety, depression, traumatic stress, as well as overall improvement in the quality of life to assess the effects of this treatment.
- Determine the duration of the clinical effects of tDCS. We will therefore compare the amelioration of pain and related symptoms between active and sham tDCS for one year following treatment.
- Determine whether tDCS changes the threshold for pain detection as compared with sham tDCS. Patients with chronic pelvic pain have a lower threshold for pain as compared to healthy subjects and we hypothesized that this threshold will increase after stimulation with tDCS.
- Finally, we will examine whether 5 days of tDCS treatment is safe for use in chronic pelvic pain patients. Safety will be assessed through neuropsychological tests and adverse event reporting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: tDCSDuring each session, the anode electrode will be placed on the motor cortex (contralateral to the most [or predominant] painful side [or the side where the symptoms begin or the left as a default]) and the cathode will be placed over the contralateral supraorbital area. In active tDCS subjects, 1 mA of transcranial direct current stimulation will be applied for 30 minutes. |
| C | Placebo comparator | Procedure: tDCSFor sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects must be females between 18 and 55 years of age.
- Subjects must have a current VAS for pelvic pain of 5 or more.
Key exclusion criteria (7 listed)
- Known pelvic malignancy.
- Patients with major depression with suicidal risk as clinically defined.
- Patients with other known, uncontrolled neuropsychiatric disorders.
- Abnormal neurological examination other than as signs of the condition studied in the present protocol.
- Contraindication to tDCS:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSDuring each session, the anode electrode will be placed on the motor cortex (contralateral to the most [or predominant] painful side [or the side where the symptoms begin or the left as a default]) and the cathode will be placed over the contralateral supraorbital area. In active tDCS subjects, 1 mA of transcranial direct current stimulation will be applied for 30 minutes. | Procedure or surgery | A |
| tDCSFor sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds. | Procedure or surgery | C |
Primary outcome
Patient Global Assessment (PGA):
Time frame: 2 weeks
Visual analog scale (VAS) for pain:
Time frame: 2 weeks
1 secondary outcome
Interstitial cystitis symptom index:
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradford W Fenton, MD, PhD principal investigator
Summa Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Chronic Pelvic Pain and Interstitial Cystitis, run by Summa Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Assessment (PGA): (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2009.